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Clinical Trials List

Protocol NumberR2810-ONC-1763
NCT Number(ClinicalTrials.gov Identfier)NCT03430063

2018-04-13 - 2022-04-13

Phase II

Terminated5

ICD-10C34

Malignant neoplasm of bronchus and lung

ICD-9162.8

Malignant neoplasm of other parts of bronchus or lung

A Randomized, Open-Label Study of Combinations of Standard and High Dose REGN2810 (Cemiplimab; Anti-PD-1 Antibody) and Ipilimumab (Anti-CTLA-4 Antibody) in the Second-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer

  • Trial Applicant

    Syneos Health

  • Sponsor

    Regeneron Pharmaceuticals

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Chao-Hua Chiu Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

2 Terminated

Audit

None

Principal Investigator Gee-chen Chang Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 張晟瑜 Division of Thoracic Medicine
Far Eastern Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 陳昭勳 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Wu-Chou Su Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Condition/Disease

Advanced Non-Small Cell Lung Carcinoma

Objectives

The primary objective of the study is to compare the objective response rate (ORR) of high dose cemiplimab (HDREGN2810) and standard dose cemiplimab plus ipilimumab combination therapy (SDREGN2810/ipi) to the ORR of standard dose cemiplimab (SDREGN2810) in the second-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC), in patients whose tumors express programmed cell death ligand 1 (PD-L1) in <50% of tumor cells.

Test Drug

REGN2810

Active Ingredient

REGN2810

Dosage Form

Injection

Dosage

50 mg

Endpoints

Primary Outcome Measures:
1. ORR.

Secondary Outcome Measures:
1. ORR in all patients.
2. Overall survival (OS) in patients whose tumors express PD-L1 in <50% of tumor cells.
3. OS in all patients.
4. Progression free survival (PFS) in patients whose tumors express PD-L1 in <50% of tumor cells.
5. PFS in all patients.
6. Incidences of treatment emergent adverse events (TEAEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grading system.
7. Incidences of serious adverse events (SAEs) as assessed by the NCI-CTCAE grading system.
8. Incidences of deaths.
9. Incidences of laboratory abnormalities as assessed by the NCI-CTCAE grading system.

Inclution Criteria

1. Patients with histologically or cytologically documented squamous or non-squamous NSCLC who either have stage IIIb or stage IIIc disease who are not candidates for treatment with definitive concurrent chemo-radiation or have stage IV disease. Patients must have PD after receiving one prior line of chemotherapy treatment for advanced NSCLC.
2. Availability of an archival or on-study obtained formalin-fixed, paraffin-embedded tumor tissue biopsy sample.
3. Biopsy evaluable for expression of PD-L1 as determined by a PD-L1 Immunohistochemistry (IHC) pharma diagnostic test (pharmDx) assay performed by a central laboratory.
4. At least 1 radiographically measureable lesion by computed tomography (CT) per RECIST 1.1 criteria.
5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.

Exclusion Criteria

1. Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime.
2. Active or untreated brain metastases or spinal cord compression.
3. Patients with tumors tested positive for epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations, or C-ros oncogene receptor tyrosine kinase (ROS1) fusions.
4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to randomization.
5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or of pneumonitis within the last 5 years.
6. Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest a risk of immunerelated treatment-emergent adverse events (irTEAEs).
7. Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of randomization.

The Estimated Number of Participants

  • Taiwan

    25 participants

  • Global

    201 participants

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